Acamprosate

Acamprosate calcium is a prescription medication that helps people who are dependent on alcohol to abstain from drinking it. It is used along with psychosocial support and helps to prevent the cravings and urge to drink alcohol that people with alcohol use disorder experience.

Drinking alcohol alters the balance of the chemical messengers or neurotransmitters in your brain. Acamprosate is thought to work by helping to restore the balance of these neurotransmitters. It's thought that it primarily works by decreasing the excessive excitation that accompanies alcohol dependence.

Acamprosate is similar in structure - an analog of - two neurotransmitters called GABA (gamma-aminobutyric acid) and taurine. And while it's not clear exactly how it works, it's been suggested that acamprosate works by targeting GABA and NMDA (N-methyl-D-aspartate) glutamatergic receptor activity. It's also been suggested that it works by supplying calcium.

In 2004, the US Food and Drug Administration (FDA) approved a branded version of acamprosate calcium called Campral. Campral has since been discontinued, but generic versions of acamprosate calcium delayed-release tablets are available.

Acamprosate is used for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Acamprosate should be used as part of a comprehensive management program that includes psychosocial support.

Acamprosate is not used to help the symptoms of alcohol withdrawal.

• Take acamprosate exactly as your doctor tells you to.
• Take two tablets three times a day or as directed by your doctor.
• Acamprosate can be taken with or without food.
• Swallow tablets whole. Do not crush or chew.

• Before starting treatment with acamprosate you must have stopped drinking alcohol.
• If you relapse and start drinking alcohol, continue to take acamprosate and see your healthcare provider as soon as possible. In the event of a relapse, treatment with acamprosate should be continued.
• Do not stop taking acamprosate, even when you feel better. Talk with your healthcare provider about how long you should take acamprosate for.
• Missing doses of acamprosate may increase your chances of relapsing.
• If you have kidney problems you may need lower doses and need blood tests while using acamprosate. If you have severe kidney problems acamprosate may not be right for you.
• People with substance use disorders are at a higher risk for depression and suicidal thoughts. If you experience any thoughts of self-harm, call 911 or go to your closest emergency room.
• Acamprosate should be used in combination with counseling and other support.

Do not take acamprosate if you are allergic to acamprosate calcium or any of the other ingredients in it. Do not use acamprosate if you have severe renal impairment.

Before taking acamprostate tell your healthcare provider about all of your medical conditions including if you:

• have kidney disease
• have depression
• have thoughts of suicide or harming yourself
• use illegal drugs or narcotics

Common side effects of acamprosate include:

• accidental injury
• asthenia
• pain
• anorexia
• diarrhea
• flatulence
• nausea
• anxiety
• depression
• dizziness
• dry mouth
• insomnia
• paresthesia
• pruritus
• sweating

These are not all of the possible side effects of acamprosate.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The recommended dose of acamprosate is 666 mg (two tablets) taken three times a day.

See full prescribing information for further details about acamprosate dosing.

Missing doses of acamprosate may increase your chances of relapsing. If you miss a dose of acamprosate take your next dose as soon as you remember. If it is nearly time for your next dose, just take the next dose at the right time. Do not take double the dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you take too much acamprosate. If you take too much acamprosate you may develop diarrhea. If you take too much acamprosate on a regular basis you may develop hypercalcemia or too much calcium in your blood.

Avoid drinking alcohol while taking acamprosate.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. Alcohol use during pregnancy can harm your unborn baby. The effects of acamprosate on the fetus are unknown, but it is thought that the drug crosses the placenta. Acamprosate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether acamprosate crosses into breastmilk. Caution should be used when prescribing acamprosate for people who are breastfeeding because the effects of it on the baby are unknown.

• Store acamprosate at 20° to 25°C (68° to 77°F).

Keep out of sight and reach of children.

Active ingredients: acamprosate calcium

Inactive ingredients:

Zydus Pharmaceuticals acamprosate tablets: microcrystalline cellulose, magnesium stearate, methacrylic acid, polyethylene glycol 8000, povidone K90, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, sodium starch glycolate type A potato, talc

Mylan Pharmceuticals acamprosate tablets: ammonia, ferrosoferric oxide, silicon dioxide, glyceryl dibehenate, unspecified hypromellose, magnesium stearate, methacrylic acid - methyl methacrylate copolymer, microcrystalline cellulose, propylene glycol, shellac, talc

Glenmark Generics acamprosate tablets: silicon dioxide, unspecified crospovidone, methacrylic acid - ethyl acrylate copolymer (1:1) type A, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate type A potato, talc, magnesium silicate, unspecified povidone

Acamprosate tablets made by other companies may contain different inactive ingredients. Check the product label for your specific version of acamprosate for a complete list of ingredients.

Generic acamprosate calcium delayed-release tablets are distributed by:

• Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534.
• Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA.
• Glenmark Pharmaceuticals Inc. Mahwah, NJ 07430 USA